Organisation and financing of health care
under-financed, with the consequence that public health-care facilities do not always have the necessary resources for treatment under the public insurance system.
- How is health care in your jurisdiction organised?
The current Romanian health-care system was set by Law No. 95/2006 regarding the reform of the health-care system (Health Care
Compliance – pharmaceutical manufacturers
Law), which creates the legal framework for the organisation and financing of the health-care system.
The Ministry of Health (MoH) and the National Health Insur- ance House (NHIH) are the main administrative bodies in charge of health care matters. MoH has strategic, regulatory, coordination and monitoring functions in most health-care areas. NHIH is the body with strategic functions regarding the public national health insurance fund. Both authorities have a pyramidal structure, with decentralised services in each county.
Another important public authority is the National Authority for Medicines and Medical Devices (NAMMD), subordinated to the MoH and enjoying large prerogatives regarding the authorisation of medicinal products and medical devices.
Other professional agencies and associations also play an impor- tant role in the administration of the health-care system.
Public health services are provided by hospitals and other health- care facilities.
- How is the health-care system financed in the outpatient and in- patient sectors?
Both outpatient and in-patient health-care services can be provided by public or private health-care facilities. Certain exceptions exist (for example, private investors cannot establish emergency health- care hospitals).
The national public health insurance is mandatory for all Roma- nian citizens and foreign residents in Romania. A significant con- tribution (as percentage from overall revenue) is paid by both the employer and the employee. Every insured person has the theoreti- cal right to receive a quite substantial basic package of services and products (medicines, medical devices), provided that such person has been taken into the evidence of a ‘family doctor’.
Persons not insured with the public system can benefit from a minimal package of services, limited mainly to medical emergencies, prevention and cure of epidemic risks, pregnancy monitoring and delivery, and family planning.
- Which legislation governs advertisement of medicinal products to the general public and health-care professionals?
General rules on the advertisement of medicinal products are laid down in title XVII, chapters VIII and IX of the Health Care Law. Advertising includes the provision of any type of information, prod- ucts (samples) or funds (sponsorships) destined to stimulate the pre- scription, distribution, sale or consumption of medicinal products.
More particular regulations on the advertisement of medicinal products are provided within the Guide for the evaluation of the advertisement for medicines for human use (Advertising Guide) issued by the NAMMD Scientific Council (No. 20/2010). The Advertising Guide has been designed to comply with EU Directive No. 92/28/EC regarding the advertising for medicinal products for human use. Under these rules, advertising consists of any activity ini- tiated, organised or sponsored by a pharmaceutical supplier aiming at encouraging the prescription, the release, the sale, the administra- tion or the consumption of a medicinal product. The Advertising Guide and the NAMMD practice seem to mainly regard the advertis- ing made by manufacturers of medicines and are not consistent or clear regarding the advertising activities initiated and carried out by entities other than suppliers (ie, distributors, pharmacies).
As a general rule, the advertising for medicinal products exclu- sively sold under medical prescription or which are not covered by a valid marketing authorisation in Romania is prohibited. It is manda- tory for all the information from the advertising material for a spe- cific medicinal product to mirror the information on the Summary of the Product Characteristics.
NAMMD is the domestic authority in charge with the moni- toring of the advertising activities on the Romanian market. The release of advertising materials for over-the-counter medicinal prod- ucts is subject to prior approval by the NAMMD. Non-compliance with legal requirements on advertising for medicinal products by manufacturers or distributors is subject to fines and other penalties provided by the law.
Public health-care facilities may carry out services on the basis of direct payment or co-payment from patients.
Private health-care facilities can become affiliated with the NHIH and in such case they may receive repayment of the basic package of health-care services and products. Private health insurance is also available from various private insurers.
The treatment or prevention of certain rare or severe diseases (eg, diabetes, multiple sclerosis, cancer, etc) are covered under various national health-care programmes and are free of charge.
In practice, the national health insurance fund system is severely
- What are the main rules and principles applying to advertising aimed at health-care professionals?
In accordance with the Health Care Law and the Advertising Guide, promotional materials for medicinal products destined to health-care professionals (ie, personnel qualified for the prescription or the release of medicinal products) must include at least the following: essential information compatible with the respective product’s characteristics; the classification for the release of that product; and information on the advertising documentation’s date and last updates. All information in the advertising documentation must be sufficiently accurate, updated and complex as to allow any health-care professional to understand the medicinal product’s therapeutic use.
Advertising for health-care professionals must not be carried through unethical means, such as offering, granting or promising gifts, pecuniary or material advantages. Health-care professionals are however allowed to receive inexpensive advantages that are related to medical or pharmaceutical activity.
Rules on the advertising for health-care professionals are also detailed in the Code for an Ethical Advertising of Medicinal Prod- ucts issued by the Romanian Association of International Produc- ers of Medicinal Products (ARPIM Ethical Advertising Code). The ARPIM Ethical Advertising Code includes detailed guidelines on specific advertising activities for health-care professionals, such as: transparency conditions for advertising campaigns, hospitality and sponsorship for health-care professionals, the distribution of samples of medicinal products, etc. The ARPIM Ethical Advertising Code does not enjoy legal force.
- What are the main rules and principles applying to advertising aimed at the general public?
Any advertising material aimed at the general public must state clearly that the product is a medicinal product and shall include information on:
- the medicinal product’s name and the corresponding active ingredient;
- instructions regarding the proper utilisation of the product; and
- a clear and express invitation for the consumer to read all instruc- tions on the product’s
Such advertising cannot:
- suggest that medical consultation is not needed;
- suggest a guaranteed treatment or improvement of the health status or suggest that the health status might worsen if that par- ticular medicine is not used;
- compare medicines;
- address to children;
- rely on endorsement made by health-care professionals or notori- ous persons;
- suggest that the medicine is food, cosmetic or other consumer product;
- suggest the safety or efficiency of the product due to its natural components,
No advertising activity aimed at the general public can be carried out regarding:
- medicinal products sold under medical prescription;
- medicinal products containing narcotic ingredients;and
- medicinal products sold under medical prescription released in the public health insurance
In addition, pharmaceutical suppliers are prohibited from directly distributing medicinal products (samples) to the general public. Advertising of medicinal products for the general public containing commercial offers (eg, ‘buy one, get one free’ offers, discounts, tying
unlawful advertising by e-mail or by other promotional means via the internet.
In NAMMD practice, penalties are applied mostly to the market- ing authorisation (MA) holders, even though, in fact, the infringe- ments may have been carried out by distributors or pharmacies without any contribution from the manufacturers.
- Under what circumstances is the provision of information regarding off- label use to health-care professionals allowed?
As a general rule, manufacturers or health-care professionals are precluded from using off-label information that would result in the advertising of a medicinal product for unauthorised uses or utilisa- tion of a medicinal product under different conditions than the ones provided by the summary of the product characteristics. Advertising for off-label use of medicinal products is solely allowed as a response to a health-care professional request.
- Which legislation governs the collaboration of the pharmaceutical industry with health-care professionals?
The provisions of the Health Care Law (articles 802 -807, title XVII) refer only to advertising rules to health-care professionals. The legis- lation does not provide a consistent set of specific rules on the wider collaboration between the pharmaceutical industry and the health- care professionals. Nonetheless, in July 2010, the MoH publicly announced that negotiations are carried out in this respect by health care authorities and the pharmaceutical industry.
- What are the main rules and principles applying to the collaboration of the pharmaceutical industry with health-care professionals?
The advertising rules contain the following general principles regard- ing such collaboration:
- health-care specialists enjoy freedom to prescribe medicines in accordance with their individual professional belief;
- pharmaceutical suppliers may conclude consultancy agreements for professional medical recommendations, with no possibility for industry players to interfere with doctors’ prescription prac- tice independence;
- health-care professionals cannot be offered, promised or pro- vided any gift, financial advantage or other benefits as an incen- tive to prescribe, purchase, provide, sell or administer a Only inexpensive gifts can be offered or given to health-care pro- fessionals (a value not exceeding e40);
- the sponsorship of an event or a health-care professional par- ticipation at conferences should always be a publicly available information;
- a supplier may not pretend the promotion or its medical prod- ucts’ acquisition in exchange of advantages granted to health- care professionals. The sponsorship must not exceed those expenditures strictly related to the medical event;
- the law also limits the number of free samples of medicines that a health-care professional can receive from suppliers in a promo- tional campaign for sales, etc.) or references to prices, discounts or any other type of price reductions, are unlawful.
6 What are the most common infringements committed by manufacturers with regard to the advertisement rules?
NAMMD statistics show that most frequent infringements regarding the advertisement rules were price related campaigns, advertising of prescription-only medicinal products, distribution of unauthorised advertising materials, the carrying out of TV or radio advertising without NAMMD’s previous approval. No sanction was applied for
- What are the most common infringements committed by manufacturers with regard to collaboration with health-care professionals?
No accurate public statistical information is available on this matter. A report issued by a commission for the analysis and elaboration of health system politics in Romania issued in July 2008 under the authority of the president of Romania suggests that pharmaceuti- cal suppliers allocate significant resources to influence a physician’s choice of prescription. Marketing and sponsorship concluded with health-care professionals are the preferred methods to give a legal appearance to such arrangements. The report does not suggest that such practices are not within legal limits.
- What are the main rules and principles applying to the collaboration of the pharmaceutical industry with patient organisations?
The law does not regulate the collaboration between pharmaceuti- cal industry and patient organisations. ARPIM has instead issued a Practice Code regarding the relations between pharmaceutical suppli- ers (ie, ARPIM members) and patient organisations (Practice Code) entered into force as of 1 April 2010.
The Practice Code contains the following principles on the matter:
- industry players must not influence the texts or any other mate- rials circulated by the patient organisations in such a way as to favour their own commercial interests;
- all partnerships between the industry players and the patient organisations must rely on mutual respect and an equally based decisional position;
- pharmaceutical suppliers cannot pretend to become a patient organisation’s sole finance sources;
- the financial or non-pecuniary support granted by the pharma- ceutical industry to patient organisations must always be clearly made public; and
- hospitality offered to patient organisations’ members must be limited to a reasonable level and strictly connect to the scope of each medical
- Are manufacturers’ infringements of competition law pursued by national authorities?
Manufacturer’s infringements of both domestic and EU competition rules are pursued by the Romanian Competition Council. The Coun- cil is also competent to examine and indicate where the health-care regulation and practice of the health-care public authorities infringes the competition rules.
There is already a substantial antitrust practice regarding the pharmaceutical industry. Record fines were applied in 2008 for unlawful market sharing agreements concluded between a major supplier of insulin products and three of its distributors in the con- text of public tenders for the acquisition of insulin for the National Diabetes Programme (Competition Council decision No. 15/2008). Significant fines were also applied to dialysis services and product providers. Also, on the basis of recommendations made by the Com- petition Council, in 2007 the national health authorities switched, in connection to acquisitions for national programmes, from a central- ised system to a decentralised (hospital) system.
Several other investigations on the pharmaceutical market are pending before the Competition Council, including an investigation for potential breach of EU parallel trade rules. The Competition Council is also about to finalise a sector inquiry on the market for the wholesale of pharmaceutical products initiated in 2009.
- Is follow-on private antitrust litigation against manufacturers possible?
Private persons (distributors, competitors, retailers, patients) may theoretically request damages before the national courts for infringe- ments of competition rules by manufacturers. Nevertheless, to our knowledge, no such proceedings exist so far.
Compliance – medical device manufacturers
- Is the advertising of medical devices and the collaboration of manufacturers of medical devices with health-care professionals and patient organisations regulated as rigorously as advertising and collaboration in the pharmaceuticals sector?
The legislation provides no specific rules on the advertising of medi- cal devices or the collaboration of medical devices manufacturers with health-care professionals and patient organisations. It is unclear whether this was a voluntary policy choice due, for example, to the fact that medical devices raise a lesser practical risk of misuse com- pared to medicinal products.
General rules on the advertising of products apply; however, these may be insufficient for medical devices that contain a medicine component.
- Which legislation sets out the regulatory framework for granting marketing authorisations and placing medicines on the market?
The Health Care Law (title XVII, chapter III) sets out the framework for the issuance of marketing authorisations and placing medicines on the market. This procedure is further detailed in the Regulations regarding the marketing authorisation and surveillance of medicinal products (Marketing Authorisation Regulation).
- Which authorities may grant marketing authorisation in your jurisdiction?
The competent authority to issue marketing authorisations for medicinal products as well as medical devices is the NAMMD.
Medicines may also be placed on the Romanian market on the basis of marketing authorisations issued by the European Medicines Agency pursuant to a centralised procedure.
- What are the relevant procedures?
The marketing authorisation procedure before NAMMD is reserved for those medicines that have not been previously authorised for marketing purposes at EU level. The duration of the authorisation procedure cannot exceed 210 days from the registration of a valid request in this respect. The authorisation documentation is submitted to an evaluation process finalised by a recommendation or rejection of the authorisation. If granted, the marketing authorisation shall contain information about the product, the prospect, the Summary of the Product Characteristics, labelling, the quality and quantity characteristics of the product and relevant data on the medicine’s manufacture.
On the basis of the EU Directive on the mutual and decentralised recognition procedures, a medicine already marketed in at least another EU member state, can be granted a marketing authorisation by means of a mutual recognition or decentralised procedure.
Under particular conditions, a special simplified authorisation procedure is provided for homeopath medicines and medicinal plants with a traditional use.
The marketing authorisation is refused if: the risks-benefits analysis is unfavourable, the therapeutic efficacy is not sufficiently proved, or the qualitative and quantitative composition does not con- form to the documentation.
A marketing authorisation is valid for five years, with an addi- tional five-year renewal option. Once renewed, the respective mar- keting authorisation becomes valid for an unlimited duration.
- Will licences become invalid if medicinal products are not marketed within a certain time? Are there any exceptions?
The marketing authorisation ceases if a medicine is not put on the market within three years of its authorisation. The same rules apply to authorised medicines previously put on the market and no longer merchandised in Romania for three years consecutively. The law also provides an exception to these rules, when the NAMMD may decide that despite the three-year market absence, exceptional reasons moti- vated by the public interest justify the extension of the marketing authorisation. Such exceptions must be rigorously justified.
- Which medicines may be marketed without authorisation?
The marketing authorisation is not necessary for radiopharmaceuti- cal products prepared by a person or an entity which, according to the national legislation, is authorised to use such medicines pursuing the supplier’s instructions, in accredited medical centres or exclu- sively using radionuclide generators, kits or radionuclide authorised precursors.
Also, a marketing authorisation is not necessary for medicines that are prepared by a pharmacy on the basis of a medical prescrip- tion recipe developed for a certain patient or a pharmacy-own recipe sold exclusively within that pharmacy.
- What, according to the legislation and case law, constitute medicinal products?
As per article 695 (1) from the Health Care Law, medicinal products consist of any substance or combination of substances for the treat- ment or prevention of human diseases or any substance or combina- tion of substances to be used or applied on humans, either for the recovery, the correction or the modification of physiological functions by means of pharmacological, immunological or metabolic actions or for establishing a medical diagnosis. The law primarily classifies medicines in accordance with their therapeutic functions and/or their composition. As to our knowledge, there is no relevant case-law par- ticularly referring to the meaning of medicinal products.
Pricing and reimbursement of medicinal products
- In which circumstances will the national health insurance system reimburse the cost of medicines?
Government Decision No. 720/2006 sets the following reimbursement levels:
- Sub-List A: medicines for the outpatient sector enjoying a 90 per cent compensation level from the minimum reference price by active substance (international common denomination); this sub-list generally regards generics that are significantly cheaper than corresponding patented medicines;
- Sub-List B: certain patented products for which the compensa- tion rate is of 50% per Retired persons with low revenues (under 700 Romanian lei) may benefit from a 90 per cent com- pensation level. The rate applies to the minimum reference price corresponding to the prescribed active substance (international common denomination);
- Sub-List C1: medicines for treatment of severe diseases (heart, hepatitis, epilepsy, Parkinson, etc) have a 100 per cent compen- sation The rate applies to the minimum reference price corresponding to the prescribed active substance (international common denomination);
- Sub-List C2: medicines covered by the national health-care pro- grammes have a 100 per cent deduction rate; this deduction rate applies to each medicine’s actual price and not to the cheapest medicine from among those covered by the same active sub- stance; and
- Sub-List C3: certain medicines destined to patients (under 26 years) and pregnant women are reimbursed at 100 per cent rate for the outpatient The rate applies to the minimum ref- erence price corresponding to the prescribed active substance (international common denomination).
Under the Framework Agreement regarding the conditions for medical assistance in the public health insurance system for 2011 to 2012, all expenditures for medication, medical materials and clinical investigations are in theory fully reimbursed by hospitals. In practice, hospitals do not have sufficient funds and even basic health-care products are sometimes lacking.
There is no regulation regarding the reimbursement of medi- cines under off-label or compassionate use. The compassionate use will likely not be reimbursed, as a prerequisite for the reimbursement would be that the medicine itself is authorised to be put on the market. Off-label use is not uncommon and there is no court practice regarding the admissibility of reimbursement in such cases. It cannot be excluded that the reimbursement would not be permit- ted unless the medicine is used within the limits of the relevant ATC 5 prescription.
21 To what extent is the market price of a medicinal product governed by law or regulation?
Manufacturers of over-the-counter (OTC) medicinal products are free to set their products’ sale prices. Manufacturers are however bound to obey free market and competition-related principles.
On the contrary, the prices for prescription-only medicinal products are regulated. MoH sets maximum manufacturer prices, maximum wholesale prices and maximum pharmacy prices for all prescription medicines. All such medicines are listed in the National Catalogue regarding reference prices for medicinal products for human use (CANAMED) reviewed periodically by the MoH (www. ms-preturi.ro).
The reference price is not always fully reimbursed by the NHIH. Government Decision No. 720/2008 set out lists of active substances and provides that reimbursement rates apply to the cheapest medicine among those covered by the same active substance (ATC 5 level). This policy obviously favours generic medicines.
- If applicable, what is the competent body for decisions regarding the pricing and reimbursability of medicinal products?
The pricing and reimbursement procedures for medicinal products are addressed by different specialised departments within the MoH and apply only for prescription-only medicines.
According with the rules set out in Order No. 75/2009 regarding the calculation of prices for medicines for human use, the reference price of medicinal products is decided upon request by the General Direction for Strategies and Medicine Policy, within 90 days from the date a complete request had been made by the manufacturer in this respect. As a general rule, a medicinal product’s reference price is decided pursuant to negotiations between the MoH and the manu- facturer and must not exceed the lowest price for the same medicine in a list of EU countries where the respective product is marketed.
The inclusion of a medicine in a reimbursement programme is accessible only to medicines included in CANAMED. MoH Order No. 318/2008 together with Annex No. 1b from Order No. 326/2009 rule the procedure for the inclusion of a medicine on a reimburse- ment list. The relevant department for deciding upon the reimburse- ment conditions is the MoH National Transparency Commission.
- Are manufacturers or distributors of medicinal products statutorily obliged to give a discount?
As mentioned above, prices for prescription-only medicines must be approved by the MoH who caps manufacturers’, wholesalers’ and retailers’ margins. MoH Order No. 75/2009 on the calculation of prices for prescription-only medicinal products contains specific ref- erences with respect to commercial conditions granted to distributors or pharmacies.
Other than that, there is no obligation for manufacturers and distributors to grant discounts or other price reductions. However, this is common practice in Romania, given the reimbursement sys- tem which limits the public spending for expensive medicines. A specialised report prepared by the a specialised commission under the president of Romania for the analysis and elaboration of health system politics in Romania (July 2008) argues that discount policies have become business mechanisms vitiating the efficient resource allocation where distributors and pharmacies are granted significant discounts to sell and promote costly medicines to final consumers.
Medicine quality and access to information
- What rules are in place to counter the counterfeiting and illegal distribution of medicines?
According to article 834 of the Health Care Law, the manufacture and trade of fake medicines is liable to criminal penalties and all parties involved in the distribution chain (ie, suppliers, distributors, retailers) must collaborate to fight against counterfeit medicines merchandised on the Romanian market. The 2006 Good Practices Guide for the Wholesale of Medicines envisages various mechanisms for the prevention or detection of counterfeit medicines sold on the Romanian market.
As a main rule, the manufacturer of medicinal products, its wholesalers and retailers must institute detailed internal rules for the notification of the NAMMD with respect to any counterfeit or defective medicinal products detection on the market. A distributor is particularly required to:
- train its personnel as to avoid the penetration in their distribution chain of fake medicines;
- put in place a quality management system allowing distributors to immediately inform the marketing authorisation holder about the identification of potentially counterfeit medicines;
- reserve particular storage locations for detected counterfeit products;
- separate the counterfeit products from other medicines during their transportation;
- contribute to the organisation of an effective traceability mecha- nism facilitating the detection of counterfeit products;
- install a written procedure for dealing with claims and infor- mation regarding medicines, including carrying out rapid and efficient withdrawals of the products; and
- safely deal with the recalls of the products from the
The NAMMD has created an active rapid alert system with respect to counterfeit products ensuring the dissemination of information to the general public about fake medicines on the market. The Euro- pean Commission ‘Pharmaceutical Package’ also has an impact on NAMMD’s activity, which intensified its cooperation with other EU member states’ authorities and the European Medicines Agency. Moreover, the NAMMD has made public a new website particu- larly dedicated to the fight against counterfeit products and illegal distribution of medicines (www.crimemedicine.ro). ANMMD has also monitored, in certain cases, the sale of products via the internet, with certain captures of illegal diet or sexual dysfunction medicines in 2009 and 2010.
Another mean of countering counterfeit and illegally distributed medicines is through rules on the protection of intellectual property rights.
- What recent measures have been taken to facilitate the general public’s access to information about prescription-only medicines?
The NAMMD website (www.anm.ro/anmdm/med.html) contains an exhaustive list and details on medicines sold on the Romanian market. The relevant national legislation does not contain additional rules on the information of the general public on medicines sold under medical prescription. The NAMMD is currently implement- ing at national level the EU Guide on the clarity of information used on the labelling and prospect for medicinal products (www.anm. ro/html/lizibilitate).
- Outline major developments to the regime relating to safety monitoring of
Title XVII, chapter X of the Health Care Law provides detailed rules on the pharmacovigilance compliance mechanism. The national authority responsible for enforcing a pharmacovigilance system in Romania is the NAMMD.
As a general rule, marketing authorisation holders are respon- sible for reporting to NAMMD and recording any cases of adverse effects for medicines. A major instrument in this respect is the Peri- odic Safety Update Reports (PSUR) Worksharing as a means of peri- odic communication with marketing authorisation holders. In line with the European Commission’s regulations, the NAMMD applies guidelines regarding the collection, verification and presentation of reports on adverse effects, technical requirements on the electronic information exchange while communicating the international medi- cal vocabulary used in this respect.
Specific technical requirements issued by NAMMD force dis- tributors to include in distribution agreements concluded with manufacturers special provisions on the pharmacovigilance compli- ance procedure. The NAMMD conducts inspections at suppliers’ and distributors’ premises in order to observe compliance with the above technical requirements and to detect any eventual or reported adverse effects.